Clinical trial · Interventional
Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
Phase II Study of Peri-Operative Modified Folfirinox in Localized Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acinar Cell Adenocarcinoma of the Pancreas | Pancreatic Acinar Cell Carcinoma | ALIAS | 0.90 |
| Duct Cell Adenocarcinoma of the Pancreas | Pancreatic Neoplasm | PROBABILISTIC | 0.70 |
| Stage IIA Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (mFOLFIRINOX)
- description
- NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection. ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: oxaliplatin
- Drug: leucovorin calcium
- Drug: irinotecan hydrochloride
- Drug: fluorouracil
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Progression Free Survival Rate
- timeFrame
- At 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologic or cytologic documentation of pancreatic adenocarcinoma * Resectable pancreatic adenocarcinoma disease as defined as follows: * No evidence of extrapancreatic disease by cross sectional imaging, PET scan, or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases; * No evidence of tumor extension to superior mesenteric artery, hepatic artery, celiac axis, aorta, or inferior vena cava, and no evidence of occlusion or encasement of the superior mesenteric vein or superior mesenteric vein/portal vein confluence, as assessed by computed tomography (CT) using pancreatic protocol (or magnetic resonance imaging \[MRI\] in patients who cannot undergo CT) and EUS * No prior treatment (chemotherapy, biological therapy, or radiotherapy) for resectable pancreatic cancer * No prior treatment with oxaliplatin, irinotecan (irinotecan hydrochloride), fluorouracil or capecitabine * Patients who received chemotherapy \> 5 years ago for malignancies other than pancreatic cancer are eligible * There is no evidence of the second malignancy at the time of study entry * \> 4 weeks since major surgery * No other concurrent anticancer therapy * Eastern Cooperative Oncology Group (ECOG) performance status: 0-1 * No other malignancy within past five years except basal cell carcinoma of the skin, cervical carcinoma in situ, or non-metastatic prostate cancer * Paraffin block or slides must be available * Adequate organ function * No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * No \>= grade 2 sensory peripheral neuropathy * No uncontrolled seizure disorder, active neurological disease, or known central nervous system (CNS) disease * No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment * No history of chronic diarrhea * Not pregnant and not nursing * No other medical condition or reason that, in the opinion of the investigator, would preclude study participation * Absolute neutrophil count \>= 1,500/uL * Platelet count \>= 100,000/uL * Hemoglobin \>= 9 g/dL * Creatinine \< 1.5 X upper limit of normal (ULN) or * Estimated glomerular filtration rate (GFR) \> 30 ml/min * Bilirubin =\< 1.5 X ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 X ULN * Negative pregnancy test in women of childbearing age
References
Publications (1)
- DERIVEDCecchini M, Salem RR, Robert M, Czerniak S, Blaha O, Zelterman D, Rajaei M, Townsend JP, Cai G, Chowdhury S, Yugawa D, Tseng R, Mejia Arbelaez C, Jiao J, Shroyer K, Thumar J, Kortmansky J, Zaheer W, Fischbach N, Persico J, Stein S, Khan SA, Cha C, Billingsley KG, Kunstman JW, Johung KL, Wiess C, Muzumdar MD, Spickard E, Aushev VN, Laliotis G, Jurdi A, Liu MC, Escobar-Hoyos L, Lacy J. Perioperative Modified FOLFIRINOX for Resectable Pancreatic Cancer: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Aug 1;10(8):1027-1035. doi: 10.1001/jamaoncol.2024.1575. PMID 38900452